Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0963-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

TFE Coated Curved Newton LLT

Product Classification:

Class II

Date Initiated: October 13, 2017

Date Posted: March 21, 2018

Recall Number: Z-0963-2018

Event ID: 79195

Reason for Recall:

Label does not state that the product is heparin-coated.

Status: Terminated

Product Quantity: 3,364

Code Information:

Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated